Integrated retractor-distractor system for use with modular bone screws

ABSTRACT

A retractor-distractor system comprising a frame with slidably coupled superior and inferior arms extending therefrom. The superior arm comprises a superior clamp arm pivotally coupled to a lateral end of the superior arm, a superior ball joint received between the superior clamp arm and the superior arm, and a superior ball joint lock operable to pivot the superior clamp arm proximate to the superior arm, thereby locking the orientation of the superior ball joint. The inferior arm comprises an inferior clamp arm pivotally coupled to a lateral end of the inferior arm, an inferior ball joint received between the inferior clamp arm and the inferior arm, and an inferior ball joint lock operable to pivot the inferior clamp arm proximate to the inferior arm, thereby locking the orientation of the inferior ball joint. The superior and inferior arms are operable to receive a modular blade to retract and distract tissue.

FIELD OF THE INVENTION

The present disclosure relates to retractor and distractor systems foruse with screws and more particularly to an integratedretractor-distractor system for use with modular bone screws.

BACKGROUND OF THE INVENTION

The spinal column of bones is highly complex anatomical structure thatincludes over 20 bones coupled to one another, housing and protectingcritical elements of the nervous system having innumerable peripheralnerves and circulatory bodies in close proximity. Despite itscomplexity, the spine is a highly flexible structure, capable of a highdegree of curvature and twist in nearly every direction. The more than20 discrete bones of an adult human spinal column are anatomicallycategorized as one of four classifications—cervical, thoracic, lumbar,or sacral—and are coupled together sequentially to one another by atri-joint complex that consists of an anterior disc and two posteriorfacet joints. The anterior discs of adjacent bones are cushioned bycartilage spacers referred to as intervertebral discs or vertebrae. Thecervical portion of the spine comprises the top of the spine up to thebase of the skull and includes the first seven vertebrae. Theintermediate 12 bones are thoracic vertebrae, and connect to the lowerspine comprising the 5 lumbar vertebrae. The base of the spine comprisessacral bones, including the coccyx. With its complex nature, however,there is also an increased likelihood that surgery may be needed tocorrect one or more spinal pathologies.

Genetic or developmental irregularities, trauma, chronic stress, tumors,and disease can result in spinal pathologies that either limit thisrange of motion or threaten critical elements of the nervous systemhoused within the spinal column. A variety of systems have beendisclosed in the art which achieve this immobilization by implantingartificial assemblies in or on the spinal column. Such systems requiresurgical implantation during a spinal surgery.

During implantation of such systems, retractors and distractors arecommonly used. After an incision is made in a patient's skin, a surgeonwill normally use a retractor to retract the patient's skin to create asurgical opening. Then, a distractor is normally used to distract twoadjacent vertebral bodies to enlarge the disk space so that the surgeoncan insert a spinal implant cage. Typically, the retractor and thedistractor are two separate instruments, which results in additionalinstruments that must be purchased prior to surgery, handled duringsurgery, and cleaned or discarded after surgery.

Therefore, it is desirable, during surgical implantation of spinaldevices, to have an integrated retractor-distractor for use with modularbone screws that allows for percutaneous delivery, independent alignmentbetween bone screws, and improved reliability, durability, and ease ofinstallment of said devices.

BRIEF SUMMARY

Disclosed herein is an integrated retractor-distractor system for usewith modular bone screws. In an embodiment, the retractor-distractorsystem comprises a frame. The frame comprises a superior arm and aninferior arm, each slidably coupled to and extending from the frame. Theframe is operable to slide the superior arm and the inferior arm in bothsuperior and inferior directions relative to the frame.

The superior arm may further comprise a superior clamp arm pivotallycoupled to a lateral end of the superior arm, a superior ball jointreceived between the superior clamp arm and the superior arm, and asuperior ball joint lock operable to pivot the superior clamp armproximate to the superior arm, thereby locking the orientation of thesuperior ball joint. The superior arm, the superior clamp arm, and thesuperior ball joint each comprise an opening within their respectiveinferior sides, the openings operable to receive a modular bladeoperable to retract and distract tissue.

The inferior arm may further comprise an inferior clamp arm pivotallycoupled to a lateral end of the inferior arm, an inferior ball jointreceived between the inferior clamp arm and the inferior arm, and aninferior ball joint lock operable to pivot the inferior clamp armproximate to the inferior arm, thereby locking the orientation of theinferior ball joint. The inferior arm, the inferior clamp arm, and theinferior ball joint each comprise an opening within their respectivesuperior sides, the openings operable to receive a modular bladeoperable to retract and distract tissue.

In an embodiment, the retractor-distractor system comprises a modularblade. The blade comprises a distal end and a proximal end, a ball jointconnecting shaft proximate to the proximal end, a retractor skinextending from the ball joint connecting shaft to the distal end, and aclamping mechanism proximate to the distal end. The clamping mechanismmay be operable to releasably attach to a modular bone screw. Themodular blade may be operable to be removably attached to the frame inthe retractor-distractor system. The retractor skin may be operable toretract and distract tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments are illustrated by way of example in the accompanyingfigures, in which like reference numbers indicate similar parts, and inwhich:

FIG. 1 depicts a perspective view of an integrated retractor-distractorsystem, in accordance with one embodiment of the present disclosure;

FIG. 2 depicts an exploded perspective view of the integratedretractor-distractor system of FIG. 1, in accordance with one embodimentof the present disclosure;

FIG. 3A depicts a perspective view of a frame of the integratedretractor-distractor system of FIGS. 1 and 2, in accordance with oneembodiment of the present disclosure;

FIG. 3B depicts a perspective view of the frame of the integratedretractor-distractor system of FIG. 3A with a modular medial bladeremovably attached, in accordance with one embodiment of the presentdisclosure;

FIG. 3C depicts a perspective view of the frame and the medial blade ofthe integrated retractor-distractor system of FIG. 3B with a driverattached, in accordance with one embodiment of the present disclosure;

FIG. 3D depicts a perspective view of the frame and the medial blade ofthe integrated retractor-distractor system of FIG. 3B with a modularsuperior blade removably attached, in accordance with one embodiment ofthe present disclosure;

FIG. 3E depicts a perspective view of the frame, the modular medialblade, and the modular superior blade of the integratedretractor-distractor system of FIG. 3D with a driver attached, inaccordance with one embodiment of the present disclosure;

FIG. 4A depicts a perspective view of a modular medial blade of theintegrated retractor-distractor system of FIG. 1, in accordance with oneembodiment of the present disclosure;

FIG. 4B depicts a sectional view of the modular medial blade of FIG. 4A,in accordance with one embodiment of the present disclosure;

FIG. 4C depicts a sectional view of the modular medial blade of FIG. 4B,in accordance with one embodiment of the present disclosure;

FIG. 5A depicts a perspective view of a modular superior/inferior bladeof the integrate retractor-distractor system of FIG. 1, in accordancewith one embodiment of the present disclosure;

FIG. 5B depicts a partial cutaway view of a clamping mechanism of themodular superior/inferior blade of FIG. 5A with a modular bone screw, inaccordance with one embodiment of the present disclosure;

FIGS. 5C-5F depict partial views of the clamping mechanism of themodular superior/inferior blade of FIG. 5B in various positions clampedaround the modular bone screw, in accordance with one embodiment of thepresent disclosure;

FIG. 6A depicts a perspective view of a superior/inferior clamp arm ofthe frame of the integrated retractor-distractor system of FIG. 1, inaccordance with one embodiment of the present disclosure;

FIGS. 6B-6C depict perspective views of a ball joint of the superiorclamp arm of FIG. 6A, in accordance with one embodiment of the presentdisclosure;

FIG. 7A depicts a partial perspective view of the inferior/superiorclamp arm of FIG. 6A with a modular bone screw and a bone screw driver,in accordance with one embodiment of the present disclosure;

FIG. 7B depicts a perspective view of the bone screw driver of FIG. 7A,in accordance with one embodiment of the present disclosure;

FIG. 7C depicts an exploded view of the bone screw driver of FIG. 7A, inaccordance with one embodiment of the present disclosure; and

FIG. 8 depicts a perspective view of a driver, in accordance with oneembodiment of the present disclosure.

DETAILED DESCRIPTION

In the embodiments described below, various components are defined inrelation to each other using the positional terms of superior/inferior,medial/lateral, and distal/proximal. In operation and while used duringspinal surgery, “superior” refers to closer to the head, while“inferior” refers to closer to the feet. “Medial” refers to closer tothe midline (spine) of the body, while “lateral” refers to away from themidline of the body. “Proximal” refers to closer to the user/surgeon,while “distal” refers to away from the user/surgeon. It is to beunderstood that the superior/inferior designations on various componentsmay be used interchangeably depending on whether the surgeon performssurgery on the spine while standing proximate to the left side of thepatient's body or proximate to the right side of the patient's body aslong as the superior direction is closer to the patient's head.

FIG. 1 depicts a perspective view of an integrated retractor-distractorsystem 100, in accordance with one embodiment of the present disclosure.The integrated retractor-distractor system 100 comprises a frame 102, amodular medial blade 104, a first modular superior/inferior blade 106 aremovably connected to a first superior/inferior sliding arm 108 a and afirst superior/inferior arm clamp 110 a, and a second modularsuperior/inferior blade 106 b removably connected to a secondsuperior/inferior sliding arm 108 b and a second superior/inferior armclamp 110 b. The first and second superior/inferior slidable arms 108 a,108 b may be L-shaped and may be operable to translate (slide) in bothsuperior and inferior directions relative to each other at a gearingsystem 116 (internal, not shown). The frame 102 may further comprise apivot arm 112.

The integrated retractor-distractor system 100 may be operable torigidly affix to a patient bedframe (not shown) at a tail frame 114. Thetail frame may be connected to a rigid arm (not shown) connected to abedframe rail (not shown) or may be connected directly to the bedframerail.

FIG. 2 depicts an exploded perspective view of the integratedretractor-distractor system 100 of FIG. 1, in accordance with oneembodiment of the present disclosure. As depicted in FIG. 2, the firstblade 106 a may be received within a first ball joint 118 a at anopening. The first ball joint 118 a may be received within openings inthe first arm clamp 110 a of the first sliding arm 108 a. The secondblade 106 b may be received within a second ball joint 118 b at anopening. The second ball joint 118 a may be received within openings inthe second arm clamp 110 b of the second sliding arm 108 b. The firstand second blades 106 a, 106 b may be locked within the first and secondball joints 118 a, 118 b with the first and second ball joint locks 120a, 120 b, respectively.

Each of the first and second ball joint locks 120 a, 120 b may comprisea screw-like shape, including a head at a proximal end and a shaft at aproximal end. The shaft may comprise a threaded portion opposite thehead and each threaded portion may be operable to be threaded throughnon-threaded apertures 126 a, 126 b defined through the first and secondarm clamps 110 a, 110 b and into and mate with threaded apertures (notshown) defined in the first and second sliding arms 108 a, 108 b. Whenreceived within and through the first and second arm clamps 110 a, 110 band the first and second sliding arms 108 a, 108 b, the first and secondball joint locks 120 a, 120 b may extend through and beyond a proximal,lower surface of the first and second sliding arms 108 a, 108 b. Theapertures 126 a, 126 b in the first and second arm clamps 110 a, 110 bmay be substantially oval in shape, allowing the first and second armclamps 110 a, 110 b to pivot relative to the first and second slidingarms 108 a, 108 b and the first and second ball joint locks 120 a, 120 bwhen the first and second ball joint locks 120 a, 120 b are receivedtherethrough. The apertures 126 a, 126 b may further comprise apertureshoulders 127 a, 127 b (not shown) within the apertures that areoperable to interact with the first and second ball joint locks 120 a,120 b, as discussed below.

As shown relative to first sliding arm 108 a, at a proximal end of thefirst ball joint lock 120 a, a burr 122 a may be attached to the balljoint lock 120 a, thereby preventing the ball joint lock 120 a frombeing entirely removed from the first arm clamp 110 a and the firstsliding arm 108 a. The burr 122 a may be a removable clip, a solderedbead, or any other burr with a diameter larger than a diameter of theaperture in the first sliding arms 108 a so that the burr 122 a cannotbe threaded through the threaded aperture.

Also shown relative to the first sliding arm 108 a, the first ball jointlock 120 a may comprise a lifting shoulder 124 a positionedapproximately halfway about the shaft of the first ball joint lock 120a. The lifting shoulder 124 a may have a diameter larger than a diameterof the aperture 126 a at the aperture shoulder 127 a so that the firstball joint lock 120 a cannot be removed through the aperture 126 a inthe first arm clamp 110 a.

In operation, the lifting shoulder 124 a may be positioned between theaperture 126 a in the first arm clamp 110 a and the threaded aperture inthe first sliding arm 108 a so that when the first ball joint lock 120 ais rotated counter-clockwise, the lifting shoulder 124 a interacts withthe aperture shoulder 127 a and causes the first arm clamp 110 a topivot upwardly. The upward pivot causes the first arm clamp 110 a to beloosened about the first ball joint 118 a, thereby allowing the firstblade 106 a multiple degrees of freedom, in both rotation andtranslation, as discussed later. When the first ball joint lock 120 a isrotated clockwise, the head of the first ball joint lock 120 a interactswith an upper surface of the first arm clamp 110 a and causes the firstarm clamp 110 a to pivot downwardly. The downward pivot causes the firstarm clamp 110 b to be tightened about the first ball joint 118, lockingthe orientation of the first blade 106 a.

Although not shown, the burr 122 a and the lifting shoulder 124 a of thefirst ball joint lock 120 a and the aperture shoulder 127 a are alsopresent on the second ball joint lock 120 b and the second aperture 126b, respectively. The second blade 106 b, the second sliding arm 108 b,the second arm clamp 110 b, the second ball joint 118 b, and the secondball joint lock 120 b operate similarly to respective components 106 a,108 a, 110 a, 118 a, and 120 a.

The integrated retractor-distractor system 100 may further comprise athird ball joint 118 c operable to receive the medial blade 104 at anopening. The third ball joint 118 c may be received within the pivot arm112. The pivot arm 112 may be tightened or loosened about the third balljoint 118 c with a pivot locking screw 128. When the pivot locking screw128 is rotated counter-clockwise, a medial end of the pivot arm 112 islowered, loosening the third ball joint 118 c and allowing the medialblade 104 multiple degrees of freedom, in both rotation and translation,as discussed later. When the pivot locking screw 128 is rotatedclockwise, the medial end of the pivot locking arm 112 is raised,tightening the ball joint 118 c and locking the medial blade 104 inplace.

FIG. 3A depicts a perspective view of the frame 102 of the integratedretractor-distractor system of FIGS. 1 and 2, in accordance with oneembodiment of the present disclosure. In addition to the elementsdescribed and related to FIGS. 1 and 2, the gearing mechanism 116 of theframe 102 further comprises a superior/inferior gearing drive 130operable to adjust the width of the superior/inferior sliding arms 108a, 108 b, and a lateral/medial gearing drive 132 operable to adjust thelateral/medial position of the pivot arm 112.

In operation, the superior/inferior sliding arms 108 a, 108 b may bemoved closer to each other when the surgeon squeezes tabs 140 a, 140 band rotates the superior/inferior gearing drive 130 in acounter-clockwise direction with a removable driver (not shown). Thesuperior/inferior sliding arms 108 a, 108 b may be moved apart from eachother when the surgeon rotates the superior/inferior gearing drive 130in a clockwise direction with a removable driver (not shown). Likewise,the pivot arm 112 may be moved in a medial direction closer to the tailframe 114 when the surgeon squeezes the tabs 140 a, 140 b and rotatesthe lateral/medial gearing drive 132 in a clockwise direction with aremovable driver (not shown) and may be moved in a lateral directionaway from the tail frame 114 when the surgeon squeezes the tabs 140 a,140 b and rotates the lateral/medial gearing drive 132 in acounter-clockwise direction with a removable driver (not shown).

FIG. 3A additionally depicts sliding arm pivot pins 134 a, 134 bconnecting arm clamps 110 a, 110 b to sliding arms 108 a, 108 b. Thepivot pins 134 a, 134 b may be located proximate to ends of the armclamps 110 a, 110 b and ends of the sliding arms 108 a, 108 b, therebyallowing the arm clamps 110 a, 110 b to pivot upwardly relative to thesliding arms 108 a, 108 b. By allowing the arm clamps 110 a, 110 b topivot, the ball joints 118 a, 118 b may be compressed when the balljoint locks 120 a, 120 b are rotated clockwise in order to locksuperior/inferior blades (not shown) in place, or may be released whenthe ball joint locks 120 a, 120 b are rotated counter-clockwise in orderto allow superior/inferior blades to be removed from the frame 102 orindependently rotated/translated relative to the frame 102.

In an embodiment, the frame 102 may further comprises a pivot arm pivotpin 136 that connects two parts of pivot arm 112 to each other. Upperpivot arm 112 a and lower pivot arm 112 b may be operable to pivotrelative to each other at the pivot arm pivot pin 136. The pivot armpivot pin 136 may be located on the frame 102 side of the ball joint 118c and proximate to the ball joint 118 c. By allowing the upper pivot arm112 a to pivot relative to the lower pivot arm 112 b, the ball joint 118c may be compressed when the pivot locking screw 128 is rotatedclockwise in order to lock the medial blade (not shown) in place, or maybe released when the pivot locking screw 128 is rotatedcounter-clockwise in order to allow the medial blade to be removed fromthe frame 102 or rotated/translated relative to the frame 102. The pivotarm pivot pin 136 also allows the upper pivot arm 112 a and the lowerpivot arm 112 b to move in unison relative to the frame 102 in bothmedial and lateral directions when the surgeon adjusts the position ofthe pivot arm 112 with the lateral/medial gearing drive 132.

The sliding arm 108 b may further comprise a ball joint locking pin 138b that is operable to extend into a center slot (not shown) in the balljoint 118 b. As discussed below, the ball joint locking pin 138 bensures that the opening of the ball joint 118 b remains aligned withthe openings in the sliding arm 108 b and the arm clamp 110 b, allowingthe superior/inferior blade 106 b to be attached to or removed from theframe 102 during surgery. Although not shown, the sliding arm 108 a andthe lower pivot arm 112 b additionally comprise ball joint locking pinsthat extend into center slots of ball joints 118 a, 118 c, respectively.These ball joint locking pins similarly ensure that the openings of theball joints 118 a, 118 c remain aligned with openings in the sliding arm108 a, the arm 110 a, the upper pivot arm 112 a, and the lower pivot arm112 b.

The arm clamps 110 a, 110 b may further comprise instrument apertures139 a, 139 b that may be located between the ball joints 118 a, 118 band the sliding arm pivot pins 134 a, 134 b and that may be operable toreceive an add-on surgical accessory or instrument such as surgicallighting.

FIG. 3B depicts a perspective view of the frame of the integratedretractor-distractor system 100 of FIG. 3A with the modular medial blade104 removably attached, in accordance with one embodiment of the presentdisclosure. FIG. 3C depicts a perspective view of the frame 102 and themodular medial blade 104 of the integrated retractor-distractor systemof FIG. 3B with a driver 142 attached, in accordance with one embodimentof the present disclosure.

As shown in FIG. 3B, when the upper pivot arm 112 a is in a loweredposition proximate to lower pivot arm 112 b and the ball joint 118 c isnot compressed, the medial blade 104 may be attached to the frame 102within the ball joint 118 c when openings in the ball joint 118 c andupper and lower pivot arms 112 a, 112 b are each aligned. In thisposition, the medial blade 104 may be “snapped” into the ball joint 118c and has multiple degrees of freedom relative to the frame 102. Themedial blade 104 may translate proximally or distally approximately 10mm about a medial blade ball joint connection shaft 144 and may rotatein three degrees of freedom.

As shown in FIG. 3C, when the medial blade 104 is placed in its desiredposition, a removable driver 142 may be used to rotate the pivot lockingscrew 128 in a clockwise rotation. When the pivot locking screw 128 isrotated in a clockwise rotation, the upper pivot arm 112 a climbs thethreads of the pivot locking screw 128, thereby clamping the ball joint118 c against the medial blade ball joint connection shaft 144 andlocking the medial blade 104 in its desired position relative to theframe 102.

FIG. 3D depicts a perspective view of the frame 102 and the modularmedial blade 104 of the integrated retractor-distractor system 100 ofFIG. 3B with a superior blade 106 a removably attached, in accordancewith one embodiment of the present disclosure. FIG. 3E depicts aperspective view of the frame 102, the modular medial blade 104, and themodular superior blade 106 a of the integrated retractor-distractorsystem 100 of FIG. 3D with the driver 142 attached, in accordance withone embodiment of the present disclosure.

As shown in FIG. 3D, when the arm clamp 110 a is in a raised position,the superior blade 106 a may be attached to the frame 102 within theball joint 118 a when openings in the ball joint 118 a, the superiorsliding arm 108 a, and the superior arm clamp 110 a are each aligned. Inthis position, the superior blade 106 a may be “snapped” into the balljoint 118 a and has multiple degrees of freedom relative to the frame102. The superior blade 106 a may translate proximally or distallyapproximately 10 mm about a superior blade connection shaft (not shown)and may rotate in three degrees of freedom.

As shown in FIG. 3E, when the superior blade 106 a is placed in itsdesired position, the removable driver 142 may be used to rotate thesuperior ball joint lock 120 a in a clockwise rotation. When thesuperior ball joint lock 120 a is rotated in a clockwise rotation, thesuperior arm clamp 110 a may be driven downwards towards the superiorsliding arm 108 a, thereby clamping the ball joint 118 a against thesuperior blade ball joint connection shaft 144 a, locking the superiorblade 106 a in its desired position relative to the frame 102.

Although not shown in FIG. 3E, an inferior superior blade is operable tofunction identically to the superior blade 106 a.

FIG. 4A depicts a perspective view of the modular medial blade 104 ofthe integrated retractor-distractor system of FIG. 1, in accordance withone embodiment of the present disclosure. The medial blade 104 comprisesthe ball joint connection shaft 144 at a proximal end that is operableto be received within a ball joint (not shown), a shoulder 145, and aretractor skin 146. The retractor skin 146 may be offset from the balljoint connection shaft 144 by the shoulder 145 and may curve outwardlyfrom the shoulder 145 substantially entirely the length of the retractorskin 146. The retractor skin 146 may extend from the shoulder 145 to adistal end at a blade edge 148. The blade edge 148 may be used to cleana pedicle or scrape tissue on a bone at the surgical site. The retractorskin 146 may further comprise internal rails 150 operable to receive amodular tool, such as a removable light.

FIG. 4B depicts a sectional view of the modular medial blade 104 of FIG.4A, in accordance with one embodiment of the present disclosure. FIG. 4Cdepicts a sectional view of the modular medial blade 104 of FIG. 4B, inaccordance with one embodiment of the present disclosure. FIG. 4Bdepicts the curvature of the retractor skin 146 away from the ball jointconnection shaft 144, the shoulder 145, and the location of the internalrails 150 proximate to edges of the retractor skin 146. FIG. 4C depictsa profile of the medial blade 104 with the ball joint connection shaft144 at a proximal end extending to the shoulder 145 and the retractorskin 146 and ending at the blade edge 148 at a proximal end.

FIG. 5A depicts a perspective view of a modular superior/inferior blade106 of the integrated retractor-distractor system 100 of FIG. 1, inaccordance with one embodiment of the present disclosure. The blade 106may be either the superior blade 106 a or the inferior blade 106 b, asdepicted in FIG. 1, as both blades have identical features and may beused interchangeably.

The blade 106 may comprise a ball joint connection shaft 152 located ata proximal end of the blade that is operable to be received within aball joint (not shown), a shoulder 154, and a retractor skin 156. Theretractor skin 156 may be offset from the ball joint connection shaft152 by the shoulder 154 and may curve outwardly from the shoulder 154substantially the entire length of the retractor skin 156. The retractorskin 156 may extend from the shoulder 154 to a distal end at a shoe base162. The blade 106 may translate proximally or distally approximately 10mm about the ball joint connection shaft 152 and may rotate in threedegrees of freedom.

The blade 106 may further comprise a clamping mechanism comprising alocking rod 158, left and right pivoting pins 160 a, 160 b, left andright clamps 164 a, 164 b, and a clamping mechanism encasement 166. Thelocking rod 158 and the left and right pivoting pins 160 a, 160 b mayextend within apertures (not shown) in the clamping mechanism encasement166 from the shoulder 154 to the shoe base 162. The locking rod 158 maybe located proximate to the ball joint connecting shaft 152 and maycomprise a locking rod head 167 above the shoulder 154 that is operableto be rotated by the driver (not shown) discussed previously. The leftand right pivoting pins 160 a, 160 b are located outside of the lockingrod 158 and extend from the shoulder 152 through apertures in the leftand right clamps 164 a, 164 b to the shoe base 162. The left and rightclamps 164 a, 164 b are operable to pivot relative to the shoe base 162between open and closed positions. Like the retractor skin 156, theclamping mechanism encasement 166 may be curved with a curvature thatmatches that of a bone screw driver (discussed below). The retractorskin 156 and the clamping mechanism encasement 166 may be manufacturedas a single part or separate parts.

FIG. 5B depicts a partial cutaway view of a clamping mechanism of themodular superior/inferior blade 106 of FIG. 5A with a modular bone screw180, in accordance with one embodiment of the present disclosure. Asdepicted in FIG. 5B, part of the retractor skin 156 and the clampingmechanism encasement 166 have been cut away to depict the internalworkings of the clamping mechanism. The left and right clamps 164 a, 164b may be curved to fit around a shaft of a bone screw in the closedposition.

The locking rod 158 may comprise a two part system with an internallocking rod 170 received within an internal aperture of an externallocking rod 168. The external locking rod 168 may comprise a firstdiameter while the internal locking rod 170 comprises a second, smallerdiameter. Both the left and the right clamps 164 a, 164 b comprise anaperture 172 a (not shown), 172 b extending therethrough and operable toreceive the locking rod 158. The apertures 172 a, 172 b are sized toreceive both the internal locking rod 170 and the external locking rod168.

The external locking rod 168 is operable to rotate about the internallocking rod 170 when the locking rod head 167 of the locking rod 160 isrotated counter-clockwise and loosened. When the external locking rod168 is withdrawn from the apertures 172 a, 172 b of the left and rightclamps 164 a, 164 b, the internal locking rod 170 remains within theapertures 172 a, 172 b. Because the internal locking rod 170 has asmaller diameter than the external locking rod 168 and the apertures 172a, 172 b, the left and right clamps 164 a, 164 are operable to pivotabove the shoe base 162 when the external locking rod 168 is withdrawnfrom the apertures 172 a, 172 b. However, because the internal lockingrod 170 is still received within the apertures 172 a, 172 b, the rangeof motion that the left and right clamps 164 a, 164 b may pivot islimited by the internal locking rod 170.

The shoe base 162 comprises an opening that allows the shoe base 162 tobe received around a shaft 184 of the bone screw 180, but a diameter ofa head 182 of the bone screw 182 is larger than the opening of the shoebase 162, preventing the superior/inferior blade 106 from being removedfrom the bone screw 180 over the head 182 of the bone screw 180.

In operation, the locking rod 157 may be rotated counter-clockwise witha removable driver (not shown), thereby withdrawing the external lockingrod 168 from the apertures 172 a, 172 b of the left and right clamps 164a, 164 b. This allows the left and right clamps 164 a, 164 b to bothpivot to an open position wherein the clamps open as wide as or widerthan the opening defined by the shoe base 162. The blade 106 may then bereceived around the bone screw 180 at the bone screw shaft 184 andproximal to the bone screw head 182. The diameter of the opening of theshoe base 162 is sized to be great than a diameter of the bone screwshaft 184, thereby allowing the bone screw 180 to pivot and rotatewithin the shoe base 162.

After the bone screw 180 has been received within the shoe base 162 andthe left and right clamps 164 a, 164 b, the left and right clamps 164 a,164 b may be tightened about the bone screw shaft 184, clamping the bonescrew 180 to the blade 106 while still allowing the bone screw 180 topivot and rotate relative to the blade 106.

When the locking rod head 167 is rotated clockwise by the removabledriver (not shown), the external locking rod 168 is driven downwardlyover the internal locking rod 170. The larger diameter of the externallocking rod 168 self-centers the apertures 172 a, 172 b of the left andright clamps 164 a, 164 b, causing the left and right clamps 164 a, 164b to both pivot inwardly and around the bone screw shaft 184. When theexternal locking rod 168 is received within the apertures 172 a, 172 bof the left and right clamps 164 a, 164 b, the left and right clamps 164a, 164 b can no longer pivot and the bone screw 180 is locked within theblade 106.

FIG. 5C, FIG. 5D, FIG. 5E, and FIG. 5F depict partial views of theclamping mechanism of the modular superior/inferior blade 106 of FIG. 5Bin various positions clamped around the modular bone screw 180, inaccordance with one embodiment of the present disclosure. In FIG. 5C,the left and right clamps 164 a, 164 b are in the closed, clampedposition and the left and right clamps 164 a, 164 b define an openingnarrower than the opening of the shoe base 162 or the diameter of thebone screw. In FIG. 5D, the locking rod has been rotatedcounter-clockwise and the external locking rod 168 has been removedabove apertures 172 a, 172 b, allowing the center of the apertures 172a, 172 b to be offset from the locking rod (collectively 168, 170) andleft and right clamps 164 a, 164 b to pivot towards an open position. InFIG. 5E, the left and right clamps 164 a, 164 b have fully pivotedoutwardly to the open position, wherein the opening created by the leftand right clamps 164 a, 164 b is the same diameter as the diameter ofopening of the shoe base 162, thereby allowing the bone screw 180 to bereceived within the superior/inferior blade 106. In FIG. 5F, the bonescrew 180 has been fully received within the superior/inferior blade 106and the locking rod has been rotated clockwise, driving the externallocking rod 168 back into and self-centering the apertures 172 a, 172 bof the left and right clamps 164 a, 164 b. In FIG. 5F, the left and theright clamps 164 a, 164 b have fully pivoted back to the closed positionand the diameter of the opening created by the left and right clamps 164a, 164 b is less than the diameter of the bone screw shaft, therebypreventing the bone screw 180 from being able to be removed from theblade 106. In the closed position, the bone screw 180 is still operableto pivot and rotate relative to the blade 106, allowing the bone screw180 to be driven into a pedicle while locked into the blade 106.

By allowing the bone screw 180 to pivot and rotate within the blade 106,the bone screw 180 may be loosely driven into the pedicle without theblade 106 being in position and then the blade 106 may be locked aroundthe bone head screw for final tightening/driving of the bone screw 180.The degrees of rotational freedom and translation created by the balljoint mechanisms (not shown), allow one or more blades 106 to be clampedaround one or bone screws that may be set in the pedicle in a largerange of orientations independent of each other.

FIG. 6A depicts a perspective view of the superior clamp arm 110 a ofthe frame 102 of the integrated retractor-distractor system 100 of FIG.1, in accordance with one embodiment of the present disclosure. FIG. 6Adepicts the superior sliding arm 108 a although the inferior sliding arm(not shown) would comprise the same components.

As shown in FIG. 6A, the ball joint 118 a comprises an elongated andwidened slot 186 a opposite the openings of the ball joint 118 a, thesliding arm 108 a, and the arm clamp 110 a. Ball joint pin 138 a extendsfrom the sliding arm 108 a into the ball joint 118 a, allowing the balljoint 118 a to rotate in three degrees of freedom while keeping theopening of the ball joint 118 a aligned with the openings of the slidingarm 108 a and the arm clamp 110 a, thereby allowing the surgeon toeasily “snap” the superior blade (not shown) into the sliding arm 108 a.As previously discussed, when the ball joint lock 120 a is rotatedcounter-clockwise, the lifting shoulder (not shown) of the ball jointlock 120 a causes the arm clamp 110 a to pivot upwardly about pivot pin134 a, allowing the ball joint 118 a to pivot about the ball joint pin138 a.

FIG. 6B and FIG. 6C depict perspective views of a ball joint 118 of thesuperior clamp arm 106 a of FIG. 6A, in accordance with one embodimentof the present disclosure. The ball joint 118 may be any of the balljoints 118 a, 118 b, and 118 c described earlier. As depicted in FIGS.6B and 6C, the ball joint 118 may comprise an elongated and widened slot186 opposite an opening 190 and a plurality of spring-loaded collets188. When a superior/inferior blade or a medial blade (not shown) isreceived within the ball joint 118 at the opening 190 and clamped(tightened) to a locked position, spacing between the collets 188disappear and an effective internal diameter of the ball joint 118 isreduced, thereby locking the ball joint 118 against the ball jointconnection shaft (not shown) of the blade.

FIG. 7A depicts a partial perspective view of the superior blade 106 areceived within the superior sliding arm 108 a and the superior clamparm 110 a of FIG. 6A with the modular bone screw 180 and a bone screwdriver 192, in accordance with one embodiment of the present disclosure.In the context of the bone screw driver 192, “proximal” refers to closerto the user/surgeon, while “distal” refers to away from theuser/surgeon.

After the superior blade 106 a has been received within the superiorsliding arm 108 a and the superior clamp arm 110 a and the bone screw180 has been clamped within the superior blade 106 a, the bone screwdriver 192 may be removably attached to the head (not shown) of the bonescrew 180 and the bone screw 180 may be driven/tightened to its finalposition in the pedicle.

FIG. 7B depicts a perspective view of the bone screw driver 192 of FIG.7A, in accordance with one embodiment of the present disclosure. FIG. 7Cdepicts an exploded view of the bone screw driver 192 of FIG. 7A, inaccordance with one embodiment of the present disclosure. The bone screwdriver 192 may comprise a head 194 at a proximal end, an internal driver202, a collar 196, and an external body 198 comprising an opening 200defined within a sidewall of the external body 198 and located at adistal end. The internal driver 202 may be received within the externalbody 198 and is operable to rotate and translate within the externalbody 198. A proximal end of the internal driver 202 may be receivedwithin the head 194 and the collar 196 may be received over a threadedproximal end of the external body 198 and the internal driver 202.

The radius of the external body 198 may be sized to be approximately thesame as the radius of the clamping mechanism encasement 166 depicted inFIG. 5A. The opening 200 may be approximately half the size of thecircumference of the proximal end of the external body 198 and is sizedto receive the head of the bone screw 180. This allows the bone screwdriver 192 to be readily attached to and detached from the bone screw180 that has already been surgically implanted into a patient. Theexternal body 198 may comprise slots along its body to allow theinternal driver 202 to be cleaned during surgery. The external body 198may further comprise markings opposite the opening 200 so that thesurgeon can easily determine where the opening 200 is located forreceiving and removing the bone screw driver 192 over the bone screw180, particularly during surgery.

In operation, when the collar 196 is rotated counter-clockwise, theinternal driver 202 is translated proximally, thus removing the distalend of the internal driver 202 from within the opening 200. The bonescrew driver 192 may then be received over the head of the bone screw180 at the opening 200. After being received over the head of the bonescrew 180, the bone screw driver 192 may be used to drive the bone screw180 into appropriate tissue, such as the pedicle region of a vertebrae.

To drive the bone screw 180, the collar 196 may be rotated clockwise,thus translating the internal driver 202 distally until it mates withthe head of the bone screw 180. The collar 196 may then be tightenedfurther relative to the external body 198. After the collar 196 has beentightened, a removable driver (not shown) can be attached to the head194 of the bone screw driver 192, rotating the internal driver 202 andthe bone screw 180 clockwise and driving the bone screw 180 further intothe pedicle.

After the bone screw 180 has been fully driven into the pedicle, thecollar 196 may be rotated counter-clockwise, allowing the internaldriver 202 to be translated proximally. When the internal driver 202 istranslated proximally, the distal end of the internal driver 202 iswithdrawn from the head of the bone screw 180 and the bone screw driver192 may be removed from the bone screw 180 through the opening 200 inthe sidewall of the external body 198. The configuration of the bonescrew driver 192 advantageously allows the bone screw driver 192 to beaffixed to the bone screw 180 in situ, drive the bone screw 180 intoplace, and then removed in situ without the risk of loosening the bonescrew 180. Since the radius of the external body 198 is approximatelythe same as the radium of the clamping mechanism encasement 166 (asshown in FIG. 5A), the bone screw driver 192, the blade 106, and thebone screw 180 act as a unitary piece, thus allowing the surgeon tomanipulate, retract, distract, and surgically install pedicle screwswith a single assembly.

FIG. 8 depicts a perspective view of the removable driver 142, inaccordance with one embodiment of the present disclosure. In the contextof the removable driver 142, “proximal” refers to closer to theuser/surgeon, while “distal” refers to away from the user/surgeon. Thedriver 142 may comprise a recess 204 at a distal end and a handle 206 ata proximal end. The recess 204 may be a square recess, a hex recess, orany other shape operable to mate with a component to be driven.

In an embodiment, the driver 142 is a T-handle driver and the recess 204may be sized and shaped to mate with and drive superior/inferior gearingdrive 130 (FIG. 3A), the lateral/medial gearing drive 132 (FIG. 3A), thesuperior/inferior ball joint locks 120 a, 120 b (FIG. 2), and the pivotlocking screw 128 (FIG. 2). The driver 142 may also be sized to drivethe head 194 of the bone screw driver 192, although in some embodiments,a larger driver may be needed to drive the head 194 of the bone screwdriver 192 in order to have sufficient torque to drive the bone screwinto the pedicle.

Advantageously, the retractor-distractor system 100 allows a surgeon tomake a small incision in the skin, insert the superior and proximalblades 106 a, 106 b through the incision, and then using the slidingarms 108 a, 108 b and the ball joints 118 a, 118 b, “toe-out” theproximal ends of the blades 106 a, 106 b so that the tissue under theskin is moved in order to expose a larger surgical area in the spinewhile still maintaining a small incision.

In addition, the retractor-distractor system 100 may be able to bedisengaged from the implanted bone screws 180 in situ while maintainingthe tissue retraction after a spinal implant cage is inserted. Then, theretractor-distractor system 100 allows extra retraction so that theproximal ends of the blades 106 a, 106 b may be moved away from the bonescrews 180 so that a tulip head can be installed onto the heads of thebone screws 180 without losing the skin retraction. The medial blade 104can be used to allow retraction on the medial/lateral side of thevertebral bodies.

The opening 200 of the bone screw driver 192 also allows the bone screwdriver 192 to securely capture and detach from a bone screw 180 in situ,while providing multiple degrees of freedom in both rotation andtranslation through the ball joints 118 a, 118 b, and 118 c. Thesuperior/inferior blades 106 a, 106 b are easy to connect to the frame102 at the ball joints 118 a, 118 b, and 118 c and may be locked inplace by compressing the ball joints.

Further, the retractor-distraction system 100 is re-usable and there areno components that are removed from the system 200 during surgery,preventing the possibility of losing any components or segments in thesurgical wound.

One or more components of the retractor-distractor system 100 disclosedherein may be made from any of the following materials: (a) anybiocompatible material (which biocompatible material may be treated topermit bone ingrowth or prohibit bone ingrowth); (b) a plastic; (c) afiber; (d) a polymer; (e) a metal (e.g., a pure metal such as titaniumand/or an alloy such as Ti—Al—Nb, TI-6Al-4V, stainless steel); (f) aradiolucent material (e.g., carbon fiber, PEEK or aluminum); or (g) anycombination thereof.

While various embodiments in accordance with the principles disclosedherein have been described above, it should be understood that they havebeen presented by way of example only, and are not limiting. Thus, thebreadth and scope of the invention(s) should not be limited by any ofthe above-described exemplary embodiments, but should be defined only inaccordance with the claims and their equivalents issuing from thisdisclosure. Furthermore, the above advantages and features are providedin described embodiments, but shall not limit the application of suchissued claims to processes and structures accomplishing any or all ofthe above advantages.

It will be understood that the principal features of this disclosure canbe employed in various embodiments without departing from the scope ofthe disclosure. Those skilled in the art will recognize, or be able toascertain using no more than routine experimentation, numerousequivalents to the specific procedures described herein. Suchequivalents are considered to be within the scope of this disclosure andare covered by the claims.

Additionally, the section headings herein are provided for consistencywith the suggestions under 37 CFR 1.77 or otherwise to provideorganizational cues. These headings shall not limit or characterize theinvention(s) set out in any claims that may issue from this disclosure.Specifically and by way of example, although the headings refer to a“Field of Invention,” such claims should not be limited by the languageunder this heading to describe the so-called technical field. Further, adescription of technology in the “Background of the Invention” sectionis not to be construed as an admission that technology is prior art toany invention(s) in this disclosure. Neither is the “Summary” to beconsidered a characterization of the invention(s) set forth in issuedclaims. Furthermore, any reference in this disclosure to “invention” inthe singular should not be used to argue that there is only a singlepoint of novelty in this disclosure. Multiple inventions may be setforth according to the limitations of the multiple claims issuing fromthis disclosure, and such claims accordingly define the invention(s),and their equivalents, that are protected thereby. In all instances, thescope of such claims shall be considered on their own merits in light ofthis disclosure, but should not be constrained by the headings set forthherein.

What is claimed is:
 1. A retractor-distractor system comprising: a framecomprising: a superior arm slidably coupled to and extending from theframe, the superior arm further comprising: a superior clamp armpivotally coupled to a lateral end of the superior arm; a superior balljoint received between the superior clamp arm and the superior arm; anda superior ball joint lock operable to pivot the superior clamp armproximate to the superior arm, thereby locking the orientation of thesuperior ball joint; wherein the superior arm, the superior clamp arm,and the superior ball joint each comprise an opening within theirrespective inferior sides, the openings operable to receive a modularblade operable to retract and distract tissue; an inferior arm slidablycoupled to and extending from the frame, the inferior arm furthercomprising: an inferior clamp arm pivotally coupled to a lateral end ofthe inferior arm; an inferior ball joint received between the inferiorclamp arm and the inferior arm; an inferior ball joint lock operable topivot the inferior clamp arm proximate to the inferior arm, therebylocking the orientation of the inferior ball joint; wherein the inferiorarm, the inferior clamp arm, and the inferior ball joint each comprisean opening within their respective superior sides, the openings operableto receive a modular blade operable to retract and distract tissue;wherein the frame is operable to slide the superior arm and the inferiorarm in both superior and inferior directions relative to the frame. 2.The retractor-distractor system of claim 1, wherein the superior balljoint and the inferior ball joint each comprise a plurality ofspring-loaded collets, wherein when the orientations of the superiorball joint and the inferior ball joint are locked, spacing between theplurality of spring-loaded collets disappears, reducing an effectiveinternal diameter of the superior ball joint and the inferior balljoint.
 3. The retractor-distractor system of claim 1 further comprisinga first modular blade comprising: a distal end and a proximal end; aball joint connecting shaft proximate to the proximal end; a retractorskin extending from the proximal end to the distal end; and wherein thefirst modular blade is operable to be removably coupled with the framewhen the ball joint connecting shaft is received within the openings inthe inferior sides of the superior arm, the superior clamp arm, and thesuperior ball joint.
 4. The retractor-distractor system of claim 3,wherein the first modular blade further comprises a clamping mechanismproximate to the distal end and operable to releasably attach to amodular bone screw.
 5. The retractor-distractor system of claim 1further comprising a second modular blade comprising: a distal end and aproximal end; a ball joint connecting shaft proximate to the proximalend; a retractor skin extending from the proximal end to the distal end;and wherein the second modular blade is operable to be removablyattached with the frame when the ball joint connecting shaft is receivedwithin the openings in the inferior sides of the superior arm, thesuperior clamp arm, and the superior ball joint.
 6. Theretractor-distractor system of claim 5, wherein the first modular bladefurther comprises a clamping mechanism proximate to the distal end andoperable to releasably attach to a modular bone screw.
 7. Theretractor-distractor system of claim 1, wherein the frame furthercomprises a pivot arm slidably coupled to and extending from the frame,the pivot arm comprising: an upper pivot arm pivotally coupled to alower pivot arm; a medial ball joint received between the upper pivotarm and the lower pivot arm; a pivot locking screw operable to pivot alateral end of the upper pivot arm proximate to a lateral end of thelower pivot arm, thereby locking the orientation of the medial balljoint; wherein the upper pivot arm, the lower pivot arm, and the medialball joint each comprise an opening about their respective lateral sidesoperable to receive a modular blade.
 8. The retractor-distractor systemof claim 7 further comprising a modular blade comprising: a distal endand a proximal end; a ball joint connecting shaft proximate to theproximal end; and a retractor skin extending from the proximal end tothe distal end; wherein the modular blade is operable to be removablyattached with the frame when the ball joint connecting shaft is receivedwithin the openings in the lateral sides of the upper pivot arm, thelower pivot arm, and the medial ball joint.
 9. The retractor-distractorsystem of claim 1, wherein the superior arm comprises a superior balljoint locking pin extending from the inferior side and into the openingof the superior arm, wherein the superior ball joint comprises anelongated slot opposite the opening of the superior ball joint, andwherein the ball joint locking pin extending from the superior arm isoperable to be received within the elongated slot of the superior balljoint, thereby allowing the superior ball joint to rotate in threedegrees of freedom while keeping the opening of the superior ball jointaligned with the openings of the superior arm and the superior armclamp.
 10. The retractor-distractor system of claim 9, wherein theelongated slot is a widened portion of the collet.
 11. Theretractor-distractor system of claim 1, wherein the inferior armcomprises an inferior ball joint locking pin extending from the superiorside and into the opening of the inferior arm, wherein the inferior balljoint comprises an elongated slot opposite the opening of the inferiorball joint, and wherein the ball joint locking pin extending from theinferior arm is operable to be received within the elongated slot of theinferior ball joint, thereby allowing the inferior ball joint to rotatein three degrees of freedom while keeping the opening of the inferiorball joint aligned with the openings of the inferior arm and theinferior arm clamp.
 12. The retractor-distractor system of claim 11,wherein the elongated slot is a widened portion of the collet.
 13. Theretractor-distractor system of claim 1, wherein the superior ball jointlock and the inferior ball joint lock each comprise a head at a proximalend and a shaft at a distal end and a lifting shoulder positionedapproximately halfway about the shaft, wherein the lifting shoulder ofthe superior ball joint lock is positioned between the superior arm andthe superior arm clamp and is operable to pivot the superior arm clampaway from the superior arm, thereby releasing the orientation of thesuperior ball joint, and wherein the lifting shoulder of the inferiorball joint lock is positioned between the inferior arm and the inferiorarm clamp and is operable to pivot the inferior arm clamp away from theinferior arm, thereby releasing the orientation of the inferior balljoint.
 14. The retractor-distractor system of claim 1, wherein the framefurther comprises an internal gearing system, wherein the internalgearing mechanism is operable to slide the inferior arm and the superiorarm in both superior and inferior directions.
 15. Theretractor-distractor system of claim 7, wherein the frame furthercomprises an internal gearing system, wherein the internal gearingmechanism is operable to slide the pivot arm in medial and lateraldirections.
 16. A modular blade operable to be used in aretractor-distractor system, the blade comprising: a distal end and aproximal end; a ball joint connecting shaft proximate to the proximalend; a retractor skin extending from the ball joint connecting shaft tothe distal end; and a clamping mechanism proximate to the distal endoperable to releasably attach to a modular bone screw; wherein themodular blade is operable to be removably attached to a frame in theretractor-distractor system; and wherein the retractor skin is operableto retract and distract tissue.
 17. The modular blade of claim 16,wherein the clamping mechanism further comprises: left and right clampsproximate to the distal end, each clamp comprising a pivot pin apertureand a locking rod aperture; a shoe base located at the distal end andcomprising an opening for receiving the modular bone screw; left andright pivoting pins extending from the shoulder to the shoe base andreceived through the left and right pivot pin apertures; a locking rodextending along the retractor skin to the distal end and receivedthrough the left and right locking rod apertures; wherein the left andright clamps are operable to pivot about the left and right pivotingpins between an open position and a closed position.
 18. The modularblade of claim 17, wherein the locking rod further comprises an internallocking rod received within an internal aperture of an external lockingrod, the external locking rod comprising a first diameter and theinternal locking rod comprises a second, smaller diameter, and thelocking rod apertures each comprise a locking rod aperture diameter,wherein the external locking rod is operable to translate distally orproximally about the internal locking rod, and wherein when the externallocking rod is translated proximally about the internal locking rod, theexternal locking rod is removed from the locking rod apertures of theleft and right clamps, thereby allowing the left and right clamps topivot between the open position and the closed position.
 19. The modularblade of claim 18, wherein when the external locking rod is translateddistally about the internal locking rod, the external locking rod isreceived within the locking rod apertures of the left and right clamps,thereby locking the left and right clamps in the closed position. 20.The modular blade of claim 19, wherein the external locking rodself-centers the left and right clamps in the closed position when theexternal locking rod is received within the locking rod apertures of theleft and right clamps.
 21. The modular blade of claim 20, wherein themodular screw is operable to rotate and pivot when the left and rightclamps are in either the open position or the closed position.
 22. Themodular blade of claim 17, wherein the clamping mechanism is receivedwithin a clamping mechanism encasement.
 23. The modular blade of claim16, wherein the retractor skin curves outwardly from a shoulderextending from a distal end of the ball joint connecting shaft.
 24. Themodular blade of claim 23, wherein the retractor skin is offset by theball joint connection shaft by the shoulder.
 25. The modular blade ofclaim 16, wherein the modular blade may translate distally or proximallyand may rotate in three degrees of freedom when the modular blade isremovably attached to the frame.
 26. The modular blade of claim 25,wherein the modular blade may be received through an incision andpivoted outwardly to retract and distract more tissue below the incisionthan at the incision.